Validation Specialist // Fulltime in Olst

Engineering

Netherlands, Olst

Fulltime

V-

Competitive

Shape the future of healthcare with us! As a Validation Specialist, you’ll play a pivotal role in ensuring the quality and safety of our life-enhancing products. Join our mission of empowering individuals to lead healthier, fulfilling lives. Apply now to make a difference!

Company

The companies mission is to enhance people’s well-being by fostering good health. Through a diverse array of scientifically-driven nutritional products, diagnostic devices, and medical equipment, we strive to empower individuals to lead fulfilling lives. Every day, they push the boundaries of innovation to discover novel approaches to enhance quality of life.

In Olst they operate a production facility dedicated to several critical tasks. These include the ongoing production of Lactulose, the formulation of hormone preparations, and the manufacture of Mebeverine. Additionally, we play a pivotal role in the filling process of the influenza vaccine, Influvac®.

What will you be doing?

The projects you will be working on are very diverse. It goes from new equipment that Is installed and initially validated to existing equipment that is upgraded and improved to the latest standards. As a Validation Specialist, you are involved from the start until the project is finished and the equipment is released for production.

Examples of equipment to be validated are:

Filling lines;

Packaging lines;

Serialization / aggregation systems;

Autoclaves;

Washers;

Cleaning validation;

Cleanroom validation;

Isolators;

Temperature mapping.

Tasks and responsibilities

Writing the validation documentation and getting the documentation approved by all involved stakeholders. Executing or supervising the validation activities (IQ, OQ, PQ);

Acting as a validation SME during audits and within project teams;

Advising on policy proposals on the implementation of new (external) developments in the field of validation and GMP;

Coaching/informing the team and other (external) colleagues in the context of validation (and its importance).

Qualification

5 years of CQV (Commissioning Qualification & Validation) experience. Possibly supplemented by CSV (Computer System Validation);

Fluent in English (Dutch is a bonus);

Team player.

The offer
We offer a competitive salary with attractive benefits.

Start date
The start date for this position is as soon as possible.

Contract
1 Year (possibility to extension)